ArthritisNCT03379545
3D MR Versus 3D CT for Glenohumeral Arthritis
A study testing 3-dimensional (3D) magnetic resonance (MR) imaging and 3D computed tomography (CT) imaging in people with Arthritis and Glenohumeral Osteoarthritis, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Glenohumeral Osteoarthritis
- What is being tested?
- 3-dimensional (3D) magnetic resonance (MR) imaging and 3D computed tomography (CT) imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2017to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from glenohumeral OA;
- Radiographic evidence of severe glenoid erosion;
- Indication for TSA based on clinical exam;
- Patient is willing to participate by complying with pre-operative visit requirements;
- Patient is willing and able to review and sign a study informed consent form.
Who cannot join
- Prior arthroplasty at the affected shoulder;
- Patients with inflammatory arthritis;
- Patients with post-capsulorrhaphy arthritis;
- Patients with post-traumatic arthritis;
- Patients with rotator cuff tear arthropathy;
- Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedures;
- Patients who are pregnant;
- Patients with implanted medical devices that are contraindicated to exposure up to a 3.0-tesla magnetic field.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Preoperative Magnetic Resonance as an Alternative to Computed Tomography Three-Dimensional Imaging for Characterizing Bone Loss in Shoulder Arthroplasty Candidates With Glenohumeral Osteoarthritis: A Prospective, Blinded, and Controlled Clinical Trial.
This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study.
- Conditions
- Arthritis, Glenohumeral Osteoarthritis
- Being tested
- 3-dimensional (3D) magnetic resonance (MR) imaging, 3D computed tomography (CT) imaging
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional (3D) magnetic resonance (MR) imagingDiagnostic test
MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.
3D computed tomography (CT) imagingDiagnostic test
The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid.
| Study group | Role | What they receive |
|---|---|---|
| 3D MR and 3D CT Imaging | Other | All shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging. Receives: Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging; Diagnostic Test: 3D computed tomography (CT) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glenoid Version
All scans from 3D CT and 3D MR imaging were reviewed carefully for the presence of any morphological changes. For the determination of glenoid version, a line was drawn between the anterior and posterior margins of the glenoid. The transverse axis of the scapula was determined by a line drawn from the midpoint of the genoid fossa to the medial end of the image of the scapula; a line drawn perpendicular to this was defined as a line of neutral version. The angle between the line of neutral version and the line connecting the anterior and posterior margins of the glenoid was measured and recorded as the Glenoid Version.
Measured: 3 Months
Glenoid Inclination
The 3D MRI glenoid inclination is measured by the two observers with the same method used for CT 3D glenoid inclination measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method. A line on the supraspinatus fossa and 3 points are drawn: Point S represents the inferior border of the glenoid, point R represents the intersection of the supraspinatus fossa line with the glenoid surface, and point A represents the vertex of the right triangle created by the line of the supraspinatus fossa and a perpendicular line passing through point S; this line (RS) is the hypotenuse of the right triangle. The inclination corresponds to the area in which the glenoid component of RSA is implanted.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start11 Jan 2017
- Primary completion21 Dec 2018
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph D Zuckerman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379545
- Sponsor's protocol ID
- 17-00500
- Status last verified
- Mar 2021
- First submitted
- 7 Dec 2017
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Magnetic Resonance as an Alternative to Computed Tomography Three-Dimensional Imaging for Characterizing Bone Loss in Shoulder Arthroplasty Candidates With Glenohumeral Osteoarthritis: A Prospective, Blinded, and Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03379545
- Acronym / sponsor ID
- 17-00500
- Conditions
- Arthritis, Glenohumeral Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D MR and 3D CT Imaging | Other | Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging, Diagnostic Test: 3D computed tomography (CT) imagingAll shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from glenohumeral OA;
- Radiographic evidence of severe glenoid erosion;
- Indication for TSA based on clinical exam;
- Patient is willing to participate by complying with pre-operative visit requirements;
- Patient is willing and able to review and sign a study informed consent form.
Key exclusion criteria (8 listed)
- Prior arthroplasty at the affected shoulder;
- Patients with inflammatory arthritis;
- Patients with post-capsulorrhaphy arthritis;
- Patients with post-traumatic arthritis;
- Patients with rotator cuff tear arthropathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-dimensional (3D) magnetic resonance (MR) imagingMRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images. | Diagnostic test | 3D MR and 3D CT Imaging |
| 3D computed tomography (CT) imagingThe CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid. | Diagnostic test | 3D MR and 3D CT Imaging |
Primary outcome
Glenoid Version
Time frame: 3 Months
All scans from 3D CT and 3D MR imaging were reviewed carefully for the presence of any morphological changes. For the determination of glenoid version, a line was drawn between the anterior and posterior margins of the glenoid. The transverse axis of the scapula was determined by a line drawn from the midpoint of the genoid fossa to the medial end of the image of the scapula; a line drawn perpendicular to this was defined as a line of neutral version. The angle between the line of neutral version and the line connecting the anterior and posterior margins of the glenoid was measured and recorded as the Glenoid Version.
Glenoid Inclination
Time frame: 3 Months
The 3D MRI glenoid inclination is measured by the two observers with the same method used for CT 3D glenoid inclination measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method. A line on the supraspinatus fossa and 3 points are drawn: Point S represents the inferior border of the glenoid, point R represents the intersection of the supraspinatus fossa line with the glenoid surface, and point A represents the vertex of the right triangle created by the line of the supraspinatus fossa and a perpendicular line passing through point S; this line (RS) is the hypotenuse of the right triangle. The inclination corresponds to the area in which the glenoid component of RSA is implanted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Zuckerman, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-dimensional (3D) magnetic resonance (MR) imaging and 3D computed tomography (CT) imaging in people with Arthritis and Glenohumeral Osteoarthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glenoid Version (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.